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Clinical Trials/NCT01938469
NCT01938469
Completed
Not Applicable

Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery

St. Luke's-Roosevelt Hospital Center1 site in 1 country33 target enrollmentSeptember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Bypass Surgery
Sponsor
St. Luke's-Roosevelt Hospital Center
Enrollment
33
Locations
1
Primary Endpoint
Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric bypass surgery (GBP).

Detailed Description

The main goal is to study the effect of meal number, size and texture on metabolism and incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small isocaloric meals, with the order of the conditions randomly assigned. The total amount of calories and the overall nutrient composition will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals. Gastric emptying will be measured by the acetaminophen test.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
July 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Severely obese patients undergoing gastric bypass surgery (GBP)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.

Time Frame: 1 month before GBP Surgery, and 12-15 months post surgery

Changes in diet induced thermogenesis after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.

Time Frame: 1 month before GBP surgery, and 12-15 months post surgery

Changes in insulin levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.

Time Frame: 1 month before GBP surgery, 12-15 months post surgery

Changes in glucose levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.

Time Frame: 1 month before GBP , 12-15 months post GBP

Changes in satiety after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.

Time Frame: 1 month before GBP, 12-15 months post GBP

Study Sites (1)

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